FDA.reportPublic FDA data

Application 085186

Type
ANDA
Sponsor
NOSTRUM LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELIXOPHYLLINTHEOPHYLLINESOLUTION, ELIXIR;ORAL80MG/15MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-4794TheophyllineTHEOPHYLLINE ANHYDROUSPharmaceutical Associates, Inc.ANDACurrent
17856-0644ELIXOPHYLLINTHEOPHYLLINE ANHYDROUSAtlantic Biologicals CorpsANDACurrent
49708-644ELIXOPHYLLINTHEOPHYLLINE ANHYDROUSCaraco Pharma, Inc.ANDACurrent
68151-0644ELIXOPHYLLINTHEOPHYLLINE ANHYDROUSCarilion Materials ManagementANDACurrent
70408-644ELIXOPHYLLINTHEOPHYLLINE ANHYDROUSNostrum Laboratories, Inc.ANDACurrent